Assessing Diagnostic Methods for Invasive Fungal Disease... | NCT06654076

Studies
Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients

NCT06654076

Sponsor

Guangzhou Institute of Respiratory Disease

Status

Completed

Last Update Posted

Nov 12, 2024Actual

Enrollment

109Actual

Phase

Not provided

Conditions

Invasive Fungal Disease
Lung Transplant Recipients
Invasive Pulmonary Aspergillosis
Pneumocystis Jirovecii Pneumonia

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Apr 30, 2023Actual

Completion Date

Aug 1, 2024Actual

First Submitted Date

Oct 21, 2024

First Submission Date that Met QC Criteria

Oct 21, 2024

First Posted Date

Oct 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2024

Last Update Posted Date

Nov 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to assess the diagnostic performance of different tests, including metagenomic next-generation sequencing (mNGS), real-time PCR, galactomannan assay, and lateral-flow device tests, in detecting invasive fungal disease in lung transplant recipients using bronchoalveolar lavage fluid samples. The study is retrospective and cross-sectional in design.

Detailed Description

This retrospective, cross-sectional study evaluates the diagnostic accuracy of various tests in detecting invasive fungal disease (IFD) in lung transplant recipients. The diagnostic methods under assessment include metagenomic next-generation sequencing (mNGS), real-time polymerase chain reaction (PCR), galactomannan (GM) assay, and lateral-flow device (LFD) testing, all performed on bronchoalveolar lavage fluid (BALF) samples. The study analyzes the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of each method for diagnosing invasive pulmonary aspergillosis (IPA) and Pneumocystis jirovecii pneumonia (PJP). The sample cohort consists of 109 lung transplant recipients, with data collected from January 2015 to April 2023

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

109Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic Accuracy of mNGS for Invasive Pulmonary Aspergillosis and Pneumocystis jirovecii Pneumonia	Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of metagenomic next-generation sequencing (mNGS) in diagnosing invasive pulmonary aspergillosis (IPA) and Pneumocystis jirovecii pneumonia (PJP) using bronchoalveolar lavage fluid (BALF) samples.	From January 2015 to April 2023

Secondary Outcomes

Measure	Description	Time Frame
Comparison of Diagnostic Accuracy between mNGS and Other Methods	Comparative analysis of diagnostic accuracy, including sensitivity and specificity, between mNGS, real-time PCR, Galactomannan (GM) assay, and lateral-flow device (LFD) tests for detecting IPA and PJP in lung transplant recipients.	From January 2015 to April 2023.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult lung transplant recipients aged 18 years and older.
Suspected cases of invasive fungal infection (invasive pulmonary aspergillosis or -Pneumocystis jirovecii pneumonia) based on clinical symptoms, radiological findings, or microbiological evidence.
Able to provide sufficient bronchoalveolar lavage fluid (BALF) samples for diagnostic testing.

Exclusion Criteria:

Patients with confirmed non-fungal infections.
Patients unable to provide adequate BALF samples for analysis.
Patients with severe comorbidities that prevent study participation or completion.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent lung transplantation and were suspected of having invasive fungal infections (IPA or PJP) based on clinical symptoms, radiological findings, or microbiological results. The study includes adults aged 18 and above who were treated at a tertiary hospital from January 2015 to April 2023.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000072742	Invasive Fungal Infections
D055744	Invasive Pulmonary Aspergillosis
D011020	Pneumonia, Pneumocystis
D009181	Mycoses

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections
D055732	Pulmonary Aspergillosis
D001228	Aspergillosis

Browse Leaves

Not provided

Browse Branches

Not provided

Description

The biospecimens used in this study were bronchoalveolar lavage fluid (BALF) samples, collected from lung transplant recipients. These samples were used for diagnostic testing, including metagenomic next-generation sequencing (mNGS), real-time PCR, galactomannan (GM) assay, and lateral-flow device (LFD) tests, to evaluate invasive fungal disease. No DNA retention for future use is applicable.